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Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure.
This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water/CO2 | Experimental | water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal |
|
| Water/Air | Experimental | Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal |
|
| CO2/CO2 | Experimental | CO2 insufflation during both colonoscope insertion and withdrawal |
|
| Air/Air | No Intervention | room air insufflation during both colonoscope insertion and withdrawal |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water immersion insertion AND CO2 insufflation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate of Minimal Sedation Colonoscopy | Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam. | six months |
| Success Rate of Minimal Sedation Colonoscopy | A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level > 3 using a 7-point Likert scale [7] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Comfort During the Procedure and During First 24 Hours After Procedure | Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Premysl Falt, MD | Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Diseases Center - Vitkovice Hospital | Ostrava | 703 84 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22569079 | Result | Falt P, Liberda M, Smajstrla V, Kliment M, Bartkova A, Tvrdik J, Fojtik P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Water/Air | Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal |
| FG001 | CO2/CO2 | CO2 insufflation during both colonoscope insertion and withdrawal |
| FG002 | Water/CO2 | water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal |
| FG003 | Air/Air | room air insufflation during both colonoscope insertion and withdrawal |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Water/Air | Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal |
| BG001 | CO2/CO2 | CO2 insufflation during both colonoscope insertion and withdrawal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Success Rate of Minimal Sedation Colonoscopy | Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam. | Not Posted | six months | ||||||||||||
| Secondary | Patient Comfort During the Procedure and During First 24 Hours After Procedure | Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Water/Air | Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal |
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There were no procedure- or sedation-related complications recorded in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Premysl Falt MD | Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic | +420602689561 | faltprem@centrum.cz |
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| Water immersion insertion | Procedure |
|
|
| CO2 insufflation | Procedure | - CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal |
|
| six months |
| BG002 | Water/CO2 | water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal |
| BG003 | Air/Air | room air insufflation during both colonoscope insertion and withdrawal |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Not Posted |
| six months |
| Primary | Success Rate of Minimal Sedation Colonoscopy | A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level > 3 using a 7-point Likert scale [7] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful. | Statistical power was calculated for the primary endpoint. A sample size of 145 subjects per insertion arm was calculated using two-tailed α = 0,05, β = 0,05, assuming that 80% versus 60% success rate in the water (Water/CO2 and Water/Air) and gas (CO2/CO2 and Air/Air) insertion arms would have been clinically relevant. | Posted | Number | percentage of all participants | 6 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | CO2/CO2 | CO2 insufflation during both colonoscope insertion and withdrawal | 0 | 0 | 0 | 0 |
| EG002 | Water/CO2 | water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal | 0 | 0 | 0 | 0 |
| EG003 | Air/Air | room air insufflation during both colonoscope insertion and withdrawal | 0 | 0 | 0 | 0 |
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